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About the Regulatory Profession

The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.

Regulatory Code of Ethics

One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.

Regulatory Competency Framework

Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.

Regulatory Convergence

Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.

ICH to Minimize Role of Industry in Harmonization Process

The International Conference on Harmonisation's (ICH) plans to implement changes to minimize the role of industry in its harmonization efforts going forward, making it the second international harmonization body this year to take efforts to exclude industry.

In a 3 July statement, ICH said its Steering Committee and Expert Working Groups had "agreed on new principles of governance for robust science-based Guidelines for the review of the safety, efficacy, and quality of medicinal products."

Industry Sidelined

As part of this agreement, regulators within ICH will assume a greater degree of "responsibility in ensuring the protection of public health, in addition to their competence to issue regulatory Guidelines."

While ICH said its decisions will continue to be made through a consensus-driven process, expert working groups will now be chaired exclusively by representatives of government regulators. Further, regulatory parties-the US, EU and Japan-will be able to unanimously start the harmonization process on a topic regardless of whether industry supports such measures, ICH said.

ICH also said it will move to make more of its internal processes transparent, and agreed to release copies of its technical documents on a regular basis. The move is expected to be incorporated into its Rules of Procedures during its next official meeting, the group said in a statement.

The move makes ICH the second international regulatory harmonization body in the last twelve months to take initiatives to reduce the input of the life science industry in the harmonization process. The Global Harmonization Task Force (GHTF) recently decided to wind down its activities and reconstitute itself as a regulator-only body known as the International Medical Device Regulators Forum (IMDRF).